Preloaded IOL injector

ABSTRACT

A preloaded intraocular lens injection device includes a retainer for releasably holding an IOL in an unstressed state. The retainer and IOL are removably attached to an injector body and are sealed in the same package for delivery to a surgeon. In an alternate embodiment, the retainer and IOL are coupled together and sealed in one package and the injector body is sealed in a separate package with the surgeon attaching the retainer to the injector body at the time of surgery. To deliver the IOL through the injector body, the retainer is removed from the injector body causing the IOL to release from the retainer and become located in an unstressed state in the injector body.

BACKGROUND OF THE INVENTION

The present invention relates to ophthalmic surgical devices andmethods. More particularly, the present invention relates to a deviceand method for inserting an intraocular lens (IOL) into an eye andwherein the IOL may be conveniently preloaded in and packaged togetherwith the injector device.

IOLs are artificial lenses used to replace the natural crystalline lensof the eye when the natural lens has cataracts or is otherwise diseased.IOLs are also sometimes implanted into an eye to correct refractiveerrors of the eye in which case the natural lens may remain in the eyetogether with the implanted IOL. The IOL may be placed in either theposterior chamber or anterior chamber of the eye. IOLs come in a varietyof configurations and materials. Some common IOL styles include theso-called open-looped haptics which include the three-piece type havingan optic and two haptics attached to and extending from the optic; theone-piece type wherein the optic and haptics are integrally formed(e.g., by machining the optic and haptics together from a single blockof material); and also the closed looped haptic IOLs. Yet a furtherstyle of IOL is called the plate haptic type wherein the haptics areconfigured as a flat plate extending from opposite sides of the optic.The IOL may be made from a variety of materials or combination ofmaterials such as PMMA, silicone, hydrogels and silicone hydrogels, etc.

Various instruments and methods for implanting the IOL in the eye areknown. In one method, the surgeon simply uses surgical forceps havingopposing blades which are used to grasp the IOL and insert it throughthe incision into the eye. While this method is still practiced today,more and more surgeons are using more sophisticated IOL inserter deviceswhich offer advantages such as affording the surgeon more control wheninserting the IOL into the eye. IOL inserter devices have recently beendeveloped with reduced diameter insertion tips which allow for a muchsmaller incision to be made in the cornea than is possible using forcepsalone. Smaller incision sizes (e.g., less than about 3 mm) are preferredover larger incisions (e.g., about 3.2 to 5+mm) since smaller incisionshave been attributed to reduced post-surgical healing time andcomplications such as induced astigmatism.

Since IOLs are very small and delicate articles of manufacture, greatcare must be taken in their handling. In order for the IOL to fitthrough the smaller incisions, they need to be folded and/or compressedprior to entering the eye wherein they will assume their originalunfolded/uncompressed shape. The IOL inserter device must therefore bedesigned in such a way as to permit the easy passage of the IOL throughthe device and into the eye, yet at the same time not damage thedelicate IOL in any way. Should the IOL be damaged during delivery intothe eye, the surgeon will most likely need to extract the damaged IOLfrom the eye and replace it with a new IOL, a highly undesirablesurgical outcome.

Thus, as explained above, the IOL inserter device must be designed topermit easy passage of the IOL therethrough. It is equally importantthat the IOL be expelled from the tip of the IOL inserter device andinto the eye in a predictable orientation and manner. Should the IOL beexpelled from the tip too quickly or in the wrong orientation, thesurgeon must further manipulate the IOL in the eye which could result intrauma to the surrounding tissues of the eye. It is therefore highlydesirable to have an inserter device which allows for precise loading ofthe IOL into the inserter device and which will pass and expel the IOLfrom the inserter device tip and into the eye in a controlled,predictable and repeatable manner.

To ensure controlled expression of the IOL through the tip of the IOLinserter device, the IOL must first be loaded into the IOL inserterdevice. The loading of the IOL into the inserter device is therefore aprecise and very important step in the process. Incorrect loading of anIOL into the inserter device is oftentimes cited as the reason for afailed IOL delivery sequence. Many IOL injector devices on the markettoday require the IOL to be loaded into the injector at the time ofsurgery by the attending nurse and/or surgeon. Due to the delicatenature of the IOL, there is a risk that the nurse and/or surgeon willinadvertently damage the IOL and/or incorrectly load the IOL into theinjector device resulting in a failed implantation. Direct handlingand/or loading of the IOL into the injector by the nurse and/or surgeonis therefore undesirable.

In a typical IOL inserter device, the IOL inserter utilizes a plungerhaving a tip which engages the IOL (which has been previously loaded andcompressed into the inserter lumen) to pass it through the inserterlumen. The IOL thus interfaces with the plunger tip as well as the lumenof the inserter device. The lumen typically is dimensioned with anarrowing toward the open tip thereof in order to further compress theIOL as it is advanced through the lumen. The tip of the lumen is sizedfor insertion through the surgical incision which, as stated above, ispresently preferred in the sub 3 mm range. Thus, an inserter lumen willtypically be dimensioned larger at the load area of the IOL andgradually decrease in diameter to the tip of the lumen where the IOL isexpressed into the eye. It will be appreciated that the compresseddiameter of the IOL at the lumen tip is the same as the inner diameterof the lumen tip, preferably sub 3 mm as stated above. Each of thesecomponent interfaces are dynamic in the sense that the forces actingbetween the interfacing components (i.e., the IOL, the plunger tip andthe inserter lumen) will vary as the IOL is pushed through the lumen.Control of these dynamic forces is therefore of utmost importance orotherwise the IOL may be damaged during delivery due to excessivecompressive forces acting thereon. For example, as the IOL is advancedby the plunger through an ever-decreasing diameter lumen, the IOL isbeing compressed while at the same time the forces necessary to push theIOL through the lumen increase. This may lead to excessive force betweenthe plunger tip and the IOL resulting in possible damage to the IOLand/or uncontrolled release of the IOL from the lumen tip. Also, theforce of the plunger tip may cause the IOL to twist and/or turn as it ismoved through the inserter whereby the force between the IOL and theplunger tip and/or the inserter lumen may uncontrollably increase to thepoint of IOL damage.

Various inserter devices have been proposed which attempt to addressthese problems, yet there remains a need for an IOL inserter and methodwhich removes the need for direct handling of the IOL by the nurseand/or surgeon and which generally simplifies operation of the IOLinjector device and IOL delivery process.

SUMMARY OF THE INVENTION

In a first aspect of the invention, an injector device is providedhaving an IOL preloaded therein and wherein the injector device and IOLare packaged together as a single unit. The IOL is releasably held by anIOL retainer in a “preloaded” position in the unstressed state; i.e., ina state where substantially no stress acts upon the optic portionthereof. In this embodiment, the device is in the preloaded positionfrom the time of final assembly and packaging at the manufacturing site,through shipping and actual use of the device by a surgeon. The storageposition is thus the position of the IOL while it is held by the IOLretainer.

The injector body includes an opening and IOL loading bay wherein theretainer removably attaches to the inserter body with the IOL capturedby the retainer and held thereby in the preloaded position. The IOLretainer includes features for releasably supporting the IOL optic. InIOLs which include one or more haptics attached to and extending fromthe optic periphery, the IOL retainer further includes features forreleasably supporting the haptic(s) as well as the optic. In thepreferred embodiment, the haptics are supported by the IOL retainer inthe preloaded position at the correct vault angle (i.e., the angle atwhich they normally extend from the optic periphery).

At manufacturing, the IOL is releasably coupled to the IOL retainer withthe optic and haptics held by IOL support elements of the retainer. Theretainer is then removably attached to the inserter body at the openingand loading bay thereof. A stripper element extends between the IOLoptic and retainer body to prevent the IOL from remaining coupled to theretainer when the retainer is removed from the inserter body. This willbe explained more fully below.

Once the device is ready to be used, the package is opened in a sterilefield of the surgical room and viscoelastic, as required, is appliedabout the IOL and/or injector body according to the desires of thesurgeon and/or directions for use provided with the packaging. The IOLretainer is then detached from the injector device. This may be done bymanually pulling the IOL retainer apart from the injector device. Inthis regard, a finger pull or other feature is provided on the body ofthe IOL retainer to facilitate manual decoupling of the retainer fromthe injector body.

As stated above, a stripper element is provided between the retainer andIOL optic. As such, as the retainer is pulled away from the injectorbody, the IOL optic presses against the stripper element which therebyprevents the IOL from staying with the retainer as the retainer isdecoupled from the injector body. Thus, the movement of the retainer asit is being decoupled from the injector device causes the IOL optic topress against the stripper element and then release from the opticsupport element of the IOL retainer, in addition to the IOL haptic(s)releasing from the haptic support elements of the IOL retainer. Oncefully released from the retainer, the IOL is in the “loaded” positionwithin the injector device and is ready to be compressed and deliveredthrough a small incision into an eye.

In an alternate embodiment of the invention, the retainer and IOLattached thereto may be packaged separately from the injector devicewhereby the retainer and IOL are attached to the injector body at thetime of surgery rather than at the time of manufacture.

The injector includes means for compressing, rolling or otherwiseforcing the IOL into a smaller cross-section for delivery through theinjector. In a preferred embodiment of the invention, the injectordevice includes a compressor which extends laterally of the IOL loadingbay of the injector body. The compressor is movable between fully openand fully closed positions and is in the open position when the injectordevice is packaged and the IOL is in the storage position. Once thepackage has been opened and the IOL retainer has been decoupled from theinjector device, the compressor is moved to the closed position whichcompresses the IOL optic. A plunger is advanced at the proximal end ofthe injector device causing the tip of the plunger to engage theproximal end of the compressed optic. As the plunger is advancedfurther, the IOL is pushed through the distal end of the injector bodyand expressed into the eye in the intended manner.

In yet a further preferred embodiment of the invention, a haptic pulleris provided at the distal end of the injector body which includes afinger for engaging the leading haptic of the IOL. Prior to fullyadvancing the plunger, the haptic puller is manually pulled away fromthe distal tip of the injector device causing the finger portion thereofto pull the leading haptic and straighten it within the distal tip ofthe injector device. This eliminates the possibility of the leadinghaptic becoming jammed inside the injector body as the plunger is beingfully advanced through the injector device.

The relative positioning of the IOL retainer, the IOL and the injectordevice is such that upon decoupling the IOL retainer from the injectordevice (and thus release of the IOL from the retainer), the IOL becomespreferentially positioned inside the injector device. The IOL thusbecomes positioned in a particular orientation inside the injectordevice relative to the plunger tip and haptic puller. This “IOL releaseposition” results in the leading haptic correctly engaging the hapticpuller, and the trailing haptic extending rearwardly of the plunger tipso that upon advancement of the plunger, the plunger tip will engage theIOL optic in the intended manner without obstruction or jamming of thetrailing haptic.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an embodiment of the invention showingthe device with the retainer and IOL coupled to the injector body in thestorage position;

FIG. 2A is a partial plan view of the injector body showing the IOLloading bay portion thereof;

FIG. 2B is a partial side elevational view in section showing thetrailing haptic residing in a recess located adjacent the plunger tipwhich is engaging the IOL optic;

FIG. 3A is an enlarged perspective view of the loading bay area of theinjector device of FIG. 1;

FIG. 3B is a cross-sectional view taken through the IOL loading bay ofthe injector device with the compressor drawer in the fully openposition;

FIG. 3C is a cross-sectional view taken along the line 3C-3C of FIG. 3A;

FIG. 3D is the view of FIG. 3C with the compressor drawer shown in thefully closed position;

FIG. 3E is a cross-sectional view taken through the IOL loading bay areaand showing an alternate embodiment of the stripper finger component ofthe injection device;

FIG. 4 is the view of FIG. 1 showing removal of the IOL retainer fromthe injector body and the compressor drawer in the fully closedposition;

FIGS. 5A-5C are perspective, top and side views of the IOL retainer withan IOL releasably held thereby;

FIG. 6 is a perspective view showing the injector device in the processof ejecting an IOL therefrom;

FIG. 7 is the view of FIG. 6 showing the IOL fully ejected from theinjector device;

FIGS. 8 and 9 are perspective and plan views of the compressor drawerand stripper finger component of the injector device, respectively;

FIG. 10 is a side elevational view of the partially preloaded embodimentof the invention showing the retainer and IOL coupled together andsealed in a single package;

FIG. 11 is a plan view of the preloaded embodiment of the inventionshowing the injector body 12, retainer 40 and IOL 30 coupled togetherand sealed in a single package; and

FIG. 12 is a cross-sectional view of the package of FIG. 11 as takengenerally along the line 12-12 in FIG. 11.

DETAILED DESCRIPTION

Referring now to the drawing, there is seen in the Figures a preferredembodiment of the invention denoted generally by the reference numeral10. In a first, broad aspect, the invention comprises a preloadedinjector device for injecting an IOL into an eye. The term “preloaded”as used herein means that the injector body 12 is packaged together withan IOL wherein the IOL 30 is held by a retainer 40 in a storage positionon the injector body (see also FIGS. 11 and 12). In an alternateembodiment of the invention, the injector device is “partiallypreloaded” meaning that the IOL 30 and retainer 40 are coupled andpackaged together but not yet coupled to the injector body 12 (see alsoFIG. 10). In this alternate embodiment, the doctor or nurse attaches theretainer and IOL to the injector body at the time of surgery.

The injector body 12 includes a longitudinal lumen 14 extending from theproximal end 16 to distal end 18 thereof. The lumen may assume anydesired cross-sectional shape although circular or oval shapes arepreferred. The lumen 14 tapers inwardly toward distal tip 18 so that theIOL 30 is gradually compressed to a very small cross-section as it exitstip 18 a. Tip 18 a may include one or more longitudinally extendingslits 18 a′ to permit a gradual expansion of the IOL 30 as it exits thetip 18 a within the eye. This prevents uncontrolled expansion of the IOLin the eye which could potentially damage the delicate surroundingtissues of the eye. Proximal end 16 may include a finger hold flange 17preferably configured with a straight edge 17 a as shown for restingdevice 10 on a flat surface. A plunger 20 having distal and proximallengths 20 a, 20 b, respectively, and a distal plunger tip 22 andproximal thumb press 24 telescopes within lumen 14 for engaging andpushing the IOL 30 through lumen 14 and out of distal tip 18 a. The IOLdelivery sequence will be explained in more detail below. It isunderstood that the overall configuration of the injector body 12 mayvary from that shown and described herein. It is furthermore understoodthat the components of the injector device may be made of any suitablematerial (e.g., polypropylene) and may be wholly or partly opaque,transparent or translucent to better visualize the IOL within theinjector device and the IOL delivery sequence.

Injector body 12 further includes an opening 26 which opens into lumen14. Opening 26 is configured to accept an IOL 30 therein for delivery ofthe IOL out distal tip 18 a. Discussion will now be turned to the IOLPreloaded Position followed by discussion of the IOL Load and DeliverySequence.

The IOL Preloaded Condition

In a preferred embodiment, device 10 includes an IOL retainer 40 usedfor releasably holding an IOL 30 in the preloaded position relative toinjector body 12. The IOL retainer 40, with IOL 30 releasably heldthereby, is removably attached to the injector body 14 at opening 26. Asseen best in FIGS. 5A-C, IOL retainer 40 includes one or more, butpreferably two optic support elements 42 a and 42 b each having a lip 42a′, 42 b′ or other feature for releasably supporting the IOL optic 31 atthe periphery 31 a thereof. Alternatively or in addition to the opticsupport elements, one or more, but preferably two haptic supportelements 44 a and 44 b are provided on retainer 40, each of whichinclude a finger 44 a′, 44 b′ or other feature for releasably supportingone or more, but preferably two haptics 33 a and 33 b which attach toand extend from the optic 31. In this regard, it is understood that theIOL configuration shown and described herein is for discussion purposesonly, and that the present invention is not to be limited thereby. Theinvention may be easily adapted to IOLs of any configuration and type(e.g., IOLs with plate, open or closed loop haptics, anterior chamberIOLs, posterior chamber IOLs, accommodating IOLs (including single anddouble lens types), etc.). The overall configuration of the IOL retainer40 may thus likewise vary so as to be cooperatively configured with andreleasably hold the particular IOL configuration being used with thedevice. In all embodiments, the retainer 40 holds at least the IOL optic31 in the unstressed state. It is furthermore preferable that retainer40 hold the IOL haptics at the correct vault angle (i.e., the angle fromwhich they normally extend from the IOL optic periphery). It is evenfurthermore preferable that the haptic support elements maintain loophaptics at the correct angle of curvature. In FIGS. 5A-C, it is seenthat the haptic support elements constrain the haptics along the outercurved edges thereof. This ensures that the haptic curvature, which isdesigned and set at manufacture of the haptics, does not increase orbend out of specification during storage of the IOL and retainer.

At manufacture, the IOL 30 is releasably secured to the IOL retainer 40.This may be done by engaging the IOL optic 31 with the IOL supportingelements 42 a, 42 b, and/or engaging the haptics 33 a, 33 b with thehaptic supporting elements 44 a, 44 b, respectively. For purposes ofdescription, haptic 33 a will be referred to as the leading haptic sinceit becomes located distally in the injector body while haptic 33 b willbe referred to as the trailing haptic since it becomes locatedproximally in the injector body (see FIG. 2).

Releasably attaching the IOL 30 to the IOL retainer 40 may be done by aworker using a pair of tweezers, for example, although other methods maybe used as desired, including automated or semi-automated means.

As discussed above, in the preloaded embodiment of the invention, theretainer 40 and IOL 30 are coupled to the injector body 12 atmanufacturing and sealed and sterilized in the same package for deliveryto the surgeon. For example, as seen in FIGS. 11 and 12, a plasticpackage 11 thermoformed to include a cavity 11 a in the general shape ofthe injector device 10 is provided for packaging device 10 together withretainer 40 and IOL 30 coupled thereto. A flexible cover sheet 11 b issealed about the perimeter of cavity 11 a to seal the package. At thetime of surgery, the cover 11 b is peeled back to access device 10.

Thus, once the IOL 30 is releasably secured to retainer 40 as describedabove, IOL retainer 40 is removably attached to the injector body atopening 26. This may be done via suitable mechanical holding featureswhich will removably connect the retainer 40 to the injector body 12,examples including friction fit, snap fit, interference fit, cooperativetabs and catches, detents, etc. As seen in FIGS. 1 and 3A, retainer 40is held in place at opening 26 via a friction fit between the surfacesdefining opening 26 and the opposite outer wall surfaces 41 a and 41 bof retainer 40. It will be seen that when retainer 40 and IOL 30 arecoupled together and attached to injector body 12, IOL optic 31 isunstressed and furthermore does not touch any part of the injector body12. This ensures the delicate IOL optic 31 will not be damaged duringstorage.

When retainer 40 and IOL 30 are coupled together and attached toinjector body 12, a stripper finger 50 is located between the IOL optic31 and the center wall surface 46 of retainer 40 as seen best in FIGS.1, 3A and 3C. The primary function of the stripper finger 50 is toprevent the IOL 30 from lifting with the retainer 40 when the retaineris detached from the injector body (this operation will be describedbelow). In a preferred embodiment of the invention, the stripper finger50 is attached to the compressor drawer 60 which is movable with respectto injector body 12 between a fully open position as seen in FIG. 3B, amid-way position seen in FIGS. 1, 3A, 3C and 3E, and the fully closedposition seen in FIGS. 3D, 4, 6 and 7. The stripper finger 50 is locatedbetween the IOL optic 31 and center wall surface 46 when the compressor60 is in the mid-way position, which is also the preloaded position ofthe injector device as described herein. When the compressor drawer 60is moved to the fully closed position, the stripper finger 50 movestherewith and comes to rest in a position laterally adjacent theinjector body 12 as seen in FIGS. 3D, 4, 6 and 7.

In an alternate embodiment, the stripper finger 50 may be formedseparate from the compressor drawer 60 if desired. One such example isseen in FIG. 3E where the stripper finger 50 is formed with a clip 50 awhich may be mounted to injector body 12 opposite to and separately ofcompressor drawer 60. In this embodiment, the stripper finger 50 isremoved from the injector body 12 after removal of retainer 40 and priorto closing the compressor drawer 60. Other embodiments will be apparentto those skilled in the art for stripping the IOL 30 from the retainer40 as the retainer is removed from the injector body 12 and are thuswithin the scope of this invention.

Referring to FIGS. 1, 2, 4, 6 and 7, it is seen that the plunger 20includes distal and proximal plunger shaft lengths 20 a, 20 b,respectively, having a plunger tip 22 at the distal end thereof and athumb press 24 at the proximal end thereof for manually operating theinjector device. The plunger tip 22 is configured for engaging the IOLoptic 31 at the periphery 31 a thereof as the plunger 20 is advancedtoward the distal tip 18 a of the injector body 12. It is very importantthat the plunger tip 22 not damage the IOL optic 31. The plunger tip 22is thus designed to prevent damage to the IOL optic 31. In the preferredembodiment, the tip is bifurcated into first and second tip portions 22a and 22 b, whereby the IOL optic periphery 31 a becomes engaged betweentip portions 22 a, 22 b as seen in FIG. 2B. It is understood that otherplunger tip designs may be used with the present invention as desired.It is furthermore preferred that the plunger shaft is rotationally fixedwithin lumen 14 to prevent unexpected rotation of the shaft (and thusthe tip 22) with the lumen 14. The plunger shaft may be rotationallyfixed by forming the proximal shaft length 20 b and lumen 14non-circular in cross-section.

In a particularly advantageous embodiment, the proximal length 20 b ofthe plunger shaft is provided with one or more elongated fingers 23 a,23 b forming springs which are biased radially outwardly against theinterior wall of lumen 14 (see FIGS. 1 and 6). The purpose of springfingers 23 a, 23 b is to provide proper centering of the plunger shaftand tip, as well as tactile resistance between the plunger 20 and thelumen 14 as the plunger 20 is advanced therethrough. In the storageposition, the plunger 20 is retracted to the position shown in FIG. 1.To ensure the plunger is not unintentionally dislodged from the injectorbody or unintentionally advanced within lumen 14, the free ends 23 a′and 23 b′ are located within respective openings 21 a, 21 b (opening 21b not shown) formed in the injector body 12 adjacent the proximal end 16thereof. When it is time to use the device, the surgeon presses upon thethumb press 24 whereupon the free ends 23 a′, 23 b′, assisted by theirslanting edge faces, disengage from respective openings 21 a, 21 b,allowing the plunger to be freely advanced in a controlled mannerthrough lumen 14. The bias of the spring fingers 23 a, 23 b against theinterior wall of the lumen 14 provides the surgeon with continuoustactile feedback allowing the surgeon to advance the plunger (and thusthe IOL) through the lumen 14 in a very concise and controlled manner.

Referring again to the plunger/IOL engagement, it is important that theIOL trailing haptic 33 b not interfere with the plunger tip/opticengagement. In this regard, the end portion of the trailing hapticlocates rearwardly of the plunger tip upon removal of retainer 40 andrelease of IOL 30 therefrom. In a preferred embodiment, a recessed area25 is provided rearwardly of tip 22 on plunger shaft length 20 a (FIG.2A). With the plunger 20 in the ready position seen in FIG. 1, therecessed area 25 of the plunger is generally aligned with the trailinghaptic 33 b of the IOL 30 held by retainer 40. As such, upon detachingretainer 40 from injector body 20, the trailing haptic 33 b will releasefrom the haptic support element 44 b and fall into recessed area 25 ofthe plunger 20. Thus, as the plunger 20 is advanced during use of thedevice in surgery, the trailing haptic 33 b will reside in recessed area25 and not become entangled or otherwise interfere with the properengagement of the plunger tip and IOL optic (FIG. 2B).

Referring to the leading haptic 33 a, it is important that the leadinghaptic not become “bunched up” inside the continuously tapering injectortip 18 as the IOL 30 is being pushed therethrough. One way to preventthis from happening is to straighten the leading haptic 33 a within tip18. To accomplish this, a haptic puller 80 is provided which is thesubject of commonly assigned U.S. Pat. No. 6,491,697, the entiredisclosure of which is hereby incorporated by reference. Haptic puller80 has a shaft 82, tip 84 and finger pull 86. At assembly, the tip 84 isinserted into the injector tip with the finger pull located outwardlyadjacent thereto (see FIG. 4). The tip 84 is configured with a lip toengage the leading haptic 33 a (see FIG. 2A). At the time of use ofdevice 10, the haptic puller 80 is grasped at finger pull 86 and pulledaway from the injector body 12 in the direction of the arrow in FIG. 6,thereby engaging and straightening the leading haptic 33 a within tip18, whereupon the haptic puller 80 may be discarded.

To ensure the leading haptic 33 a becomes engaged with the haptic pullertip 84 when the IOL retainer 40 is removed from injector body 12, thehaptic puller tip 84 is positioned in injector tip 18 in alignment withthe leading haptic 33 a as it is held by the haptic supporting element44 a of IOL retainer 40. Thus, upon detaching IOL retainer 40 from theinjector body 12, the leading haptic 33 a releases from the hapticsupporting element 44 a and falls into place on the haptic puller tip 84as shown in FIG. 2A.

The IOL Loaded Condition and Delivery Sequence

When it is time to use the injector device 10, the surgeon selects theinjector device with the appropriate IOL preloaded therein as describedabove. The outer packaging is removed in a sterile field of the surgicalsuite. To load the IOL into the delivery position seen in FIG. 2A, thenurse or surgeon grasps and removes IOL retainer 40 from injector body12. This is accomplished by manually grasping finger grip 41 and pullingthe retainer 40 away from the injector body 12 as shown by directionalarrow 1 in FIG. 4. As described above, the stripper finger 50 acts toprevent the IOL 30 from lifting together with retainer 40. Thus, the IOLoptic 31 will release from the IOL optic support element 42 a, 42 b andthe leading and trailing haptics 33 a, 33 b will release from theirrespective haptic support elements 44 a, 44 b. Once the retainer 40 hasbeen fully detached from injector body 12, it may be discarded orrecycled. With the IOL 30 thus fully released from retainer 40, the IOLoptic 31 comes to rest in the loading bay area 27 of the injector lumen14 with the leading haptic 33 a engaging the haptic puller tip 84 andthe trailing haptic 33 b locating in the recessed area 25 adjacent theplunger tip 22 as described above. In this regard, it is noted that uponrelease of the IOL 30 from the retainer 40, IOL 30 will drop slightly inlumen 14. This is seen best in FIGS. 3C and 3D where in FIG. 3C, IOL 30is held by retainer 40 with the optic periphery 31 a located slightlyabove groove 14 a which is formed in and extends longitudinally alongthe inside wall of lumen 14. Upon removal of retainer 40 and release ofIOL 30 therefrom, the optic periphery 31 a becomes aligned with groove14 a along one side of the lumen. Then, upon moving compressor drawer 60to the fully closed position (see directional arrow 2 in FIG. 4), theopposite edge of the optic periphery 31 a becomes engaged in groove 60 aof drawer 60 (see also FIG. 8). Thus, lumen 14 together with lumengroove 14 a, drawer groove 60 a, and drawer top wall 60 b compresses andencases IOL optic 31 within lumen 14. The locating of the opticperiphery 31 a inside opposite grooves 14 a and 60 a ensures a planardelivery of the IOL 30 through lumen 14 and out tip 18. This manner ofIOL planar delivery is described in more detail in commonly assignedU.S. Pat. No. 6,491,697 referred to above.

Prior to removing retainer 40, closing drawer 60 and compressing the IOL30 inside the injector body, it may be desirable to apply viscoelasticto the area surrounding the IOL 30 to ease delivery of the IOL throughthe injector body. This is a common practice in the industry and theamount and location of viscoelastic application varies according to theinstructions for use provided with the device as well as the desires ofthe surgeon. In any event, in a preferred embodiment, one or moreviscoelastic access ports are provided on the injector device tofacilitate application of the viscoelastic in the area of the IOL. Oneor more access ports P₁ may thus be provided in the form of athrough-hole in stripper finger 50. The access port P₁ is accessible viaan injection nozzle inserted into visco port P₁. Alternatively or inaddition to access ports P₁, one or more access ports P₂ may be providedat any desired location through the wall of tip 18 (see FIGS. 3B-D).Alternatively or in addition to visco ports P₁ and P₂, visco may beapplied in loading bay 27 at the openings P₃ and P₄ defined between theoptic and haptic support elements of retainer 40 (see FIG. 3A). Once theviscoelastic has been applied as desired, retainer 40 is removed and thecompressor drawer 60 is moved to the fully closed position whereupon theIOL optic 31 is compressed and ready for delivery through a smallincision formed in an eye. The fully closed position of drawer 60 andcompressed position of the IOL 30 is seen in FIG. 3D as described above.Drawer 60 is slidably received between cooperatively formed drawerslides 61 a, 61 b extending laterally from injector body 12 adjacentopening 26. Detents or other features (not shown) may be provided on thefacing surfaces of drawer slides 61 a, 61 b and drawer 60 to assist inmaintaining drawer 60 in the fully open and mid-way positions,respectively. Such drawer holding features are especially useful inpreventing unintentional sliding and/or complete closing of drawer 60prior to the time needed (e.g., during storage or opening of device 10from its associated packaging).

At this time, the haptic puller 80 is pulled away from the injector body12 (FIG. 6) and the leading haptic 33 a is straightened within injectortip 18. If desired or required, the plunger 20 may be advanced slightlyprior to removing the haptic puller 80. The surgeon inserts the injectortip 18 a into the incision cut into the eye and begins advancing theplunger 20. As the plunger 20 is advanced, the plunger tip 22 engagesthe optic periphery 31 a and pushes IOL 30 forwardly with the trailinghaptic 33 b remaining located in recess 25 of plunger 20. Upon continuedadvancement of the plunger 20, the IOL 30 is pushed through the injectortip 18 a and is finally expressed therefrom and into the eye (FIG. 7). Ahelical spring 27 may be provided about plunger shaft distal length 20 ato provide increasing bias in the reverse direction as the plungerreaches the fully advanced position. This occurs as spring 27 iscompressed between the leading edge 20 b′ of proximal shaft length 20 band the radial extension 12 a of injector body 12 (see FIGS. 1 and 6).This assists the surgeon in maintaining precise control over plunger(and hence IOL) advancement and allows automatic retraction of theplunger upon relieving the pushing pressure being exerted against theplunger thumb press 24. This is useful for easily executing a secondstroke of the plunger in order to engage and manipulate the trailinghaptic into place in the eye. This feature, together with the bifurcatedplunger tip 22, allows a more precise control and manipulation of theIOL with the plunger tip in-situ than would be possible with an injectordevice not having these features.

The Partially Preloaded Condition

In an alternate embodiment of the invention, rather than being fullypreloaded as described above, the injector device is “partiallypreloaded”, meaning that the IOL 30 and retainer 40 are coupled togetheras shown in FIGS. 5A-C and sealed in a package 51 as shown in FIG. 10which is separate from another package in which the injector body 12 issupplied. Package 51 may be thermoformed to include a cavity 51 a in thegeneral shape of retainer 40 and IOL 30 as coupled together. A flexiblecover sheet 51 b is sealed about the perimeter of cavity 51 a to sealthe retainer 40 and IOL 30 in package 51. This embodiment allows thedoctor to choose a package having a retainer and specific IOL modeltherein. This is then combined with the separately packaged injectorbody 12 which is common to all IOL models. Thus, in this alternateembodiment, the doctor or nurse removes cover 51 b to retrieve retainer40 and IOL 30 therefrom. The injector body 12 is removed from itsrespective packaging and the retainer 40 having an IOL 30 alreadycoupled thereto is attached to the injector body 12 at the time ofsurgery. It will be appreciated that direct handling and manipulation ofthe IOL 30 itself is not required in either the preloaded or partiallypreloaded embodiments of the invention.

In the partially preloaded embodiment, the injector body 12 is suppliedwith the compressor drawer 60 in the fully open position seen in FIG. 3Bsuch that the stripper finger 50 is located laterally adjacent theopening 26 (or the stripper finger is not yet attached to the injectorbody 12 where the stripper finger is a separate component). The nurse ordoctor then opens the package housing the inserter body and proceeds tocouple the retainer and IOL to the injector body through opening 26.Once the retainer 40 and IOL 30 are coupled to the inserter body 12, thestripper finger 50 is inserted between the retainer wall surface 46 andIOL optic 31. This may be done by advancing the compressor drawer 60 tothe mid-way position seen in FIGS. 1, 3A and 3C. In the embodiment shownin FIG. 3E, this is accomplished by attaching the stripper finger 50 andclip 50 a combination to the injector body 12 opposite drawer 60.

1. An IOL injector device comprising: a) an injector body having a lumenwith a longitudinal axis; b) a retainer releasably supporting an IOL,said retainer removably connected to said injector body; c) a compressorcoupled to and moveable relative to the injector body in a directiontransverse to the longitudinal axis, the compressor adapted to compressthe IOL; d) a stripper finger fixedly coupled to the injector body andextending between the retainer and the IOL, the compressor moveableindependent of the stripper finger, the injector body, stripper fingerand the retainer configured such that, upon removal of said retainerfrom said injector body, the stripper finger causes the retainer torelease said IOL such that said IOL is disposed on said injector body.2. The injector device of claim 1 wherein said retainer is configured tohold said IOL in an unstressed condition.
 3. The injector device ofclaim 1 wherein said retainer is configured to locate said IOL withinsaid injector body in an unstressed condition.
 4. The injector device ofclaim 1 wherein said stripper finger is attached to a clip adapted to beremovably attached to the injector body.
 5. The injector device of claim1 wherein the stripper finger includes a through-hole comprising aviscoelastic access port.
 6. The injector device of claim 1 wherein theinjector body includes a through-hole comprising a viscoelastic port. 7.The injector device of claim 1, further comprising a haptic pullerhaving a haptic puller tip positioned in the lumen in the preloadedcondition of the IOL injection device, said haptic puller tip configuredto engage a leading haptic of the IOL and subsequently straighten theleading haptic within the distal tip of the injector body upon removingthe haptic puller from the injector body.
 8. The injector device ofclaim 1, further comprising a p1unger including a plunger tip forengaging the IOL, and a recess formed in said plunger adjacent saidplunger tip, said recess adapted to locate a trailing haptic of the IOLrearwardly of said plunger tip.
 9. The injector device of claim 1,further comprising a plunger including proximal and distal shaftlengths, and further comprising one or more spring finger elementsattached to said proximal shaft length and operable to apply a biasingforce against the interior of the injector body lumen as said plunger ispushed through said injector body.
 10. The injector device of claim 9,wherein said injector body includes proximal and distal ends, andfurther comprising one or more openings formed therethrough adjacent theproximal end thereof and wherein said one or more spring fingers eachhave a respective free end which may be removably located in arespective said opening.
 11. The injector device of claim 1, furthercomprising a plunger including proximal and distal shaft lengths, saidproximal shaft length being cooperatively configured with said lumen soas to rotationally fix said plunger with respect to said lumen.
 12. Theinjector device of claim 11, wherein said proximal shaft length includesa leading edge and said lumen includes a radial extension, and furthercomprising a helical spring attached to said plunger distal shaft lengthand compressible between said leading edge and said radial extension assaid plunger is advanced through said injector body.
 13. The IOLinjector device of claim 1, wherein the injector device and the retainerare configured such that separation of the injector device and theretainer causes the IOL to locate in the lumen.
 14. An IOL injectionapparatus, comprising: a) an IOL b) an injector body comprising a lumen;c) a retainer adapted to releasably support the IOL, and adapted toremovably couple to the injector body, p1 d) a stripper finger that isdistinct from portions of the injector body that define the lumen,rigidly positioned between the retainer and the IOL, the injector bodyand the retainer configured to couple together such that, when theretainer is supporting the IOL, decoupling of the retainer from theinjector body causes the retainer to release said IOL such that the IOLis disposed on said injector body.
 15. The injector device of claim 14,wherein the retainer is configured to hold said IOL in an unstressedcondition.
 16. The injector device of claim 14, wherein said retainerand injector body are configured to locate said IOL on said injectorbody in an unstressed condition after decoupling.